ADAP ADVOCACY
ASSOCIATION
2013 HIV/HCV
CO-INFECTION SUMMIT
Lynda Dee
Fair Pricing Coalition
DRUG DEVELOPMENT & PRICING
OVERVIEW
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HCV Drug Development by Company
Pricing & Price Increase Factors
Annual Average HIV Price Increases
HCV Price Increases Since Approval
Company Assessments
WAC Prices
Review of Approved HCV Drug Prices
Projections: Janssen, Gilead and Abbott
FPC Members & Contact Information
ABBVIE (ABBOTT) HCV DRUGS
IN DEVELOPMENT
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ABT 450/r + ABT 072 + ribavirin (RBV)
ABT 450/r + ABT333 + RBV
ABT 450: Boosted protease inhibitor
ABT 072: N/nucls polymerase inhibitor
ABT 333: N/nucls polymerase inhibitor
Expected filing date: Mid-2014
BOEHRINGER INGELHEIM (BI)
HCV DRUGS IN DEVELOPMENT
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BI7335/r (faldaprevir) + INF/RBV (PI)
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Expected filing date: 2014
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BI7127 + INF/RBV (n/nucls polymerase)
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Expected filing date: 2015
BMS HCV DRUGS IN
DEVELOPMENT
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Daclatasvir (DLV) + INF/RBV (NS5A inhibitor)
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Asunaprevir + INF/RBV (protease inhibitor)
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DCV + APR + BMS 791325 (n/ns polymerase)
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Expected filing date: 2014
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INF/Lambda: HBV & HCV - Less side effects
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Expected filing date: 2015
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BMS 986094 (nucleotide NS5B) discontinued
GENENTECH/ROCHE HCV
DRUGS IN DEVELOPMENT
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Mericitabine (RG7128) + INF/R:
Non-nucleotide polymerase inhibitor
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Danoprevir/r (RG7227) + INF/R
Protease inhibitor
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Expected filing date: Unknown
GILEAD HCV DRUGS IN
DEVELOPMENT
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Sofosbuvir (7977 nucleotide)+ INF/R or RBV
Filed: 4-9-13 (G1, 4, 5, 6 + INF/R, G2, 3 + RBV)
Sofosbuvir + ledipasvir (5885) (NS5A)
Expected filing date: 2014
Sofosbuvir + daclatasvir (BMS NS5A)
Sofosbuvir + simeprevir (Janssen PI)
No expected filing date: ACTG Phase 4
GSK NEW DRUGS IN
DEVELOPMENT
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GSK 2336805 (NS5A) + Simeprevir (PI)
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GSK 2336805 + VX 135 (polymerase)
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No expected filing date
IDENTIX
DISCONTINUED DRUGS
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IDX 183 (nucleotide NS5B)
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IDX 19368
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Effective, but toxic: cardio events
JANSSEN HCV DRUGS IN
DEVELOPMENT
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Simeprevir (TMC 435) + INF/RBV (protease)
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NDA filed: March 30, 2013
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Simeprevir (SPV) + GSK 2336805 (NS5A)
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SPV + sofosbuvir (Gilead 7977)
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SPV + TMC 647055 (n/ncs) + IDX 719 (NS5A) +/- RBV
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No expected filing date
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Phase 4 trials in the ACTG
MERCK HCV DRUGS IN
DEVELOPMENT
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Victrelis approved 2011 (protease inhibitor)
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MK 5172 + INF/RBV (protease inhibitor)
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Expected filing date: 2015
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MK 5172 + MK 8742 (NS5A inhibitor)
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Expected filing date unknown
VERTEX HCV DRUGS IN
DEVELOPMENT
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Incivek approved 2011 (protease inhibitor)
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VX 222 (VCH 222) (non-nucleoside polymerase)
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VX 222 + Incivek + RBV
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VX 135 + simeprevir (Janssen protease)
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VX 135 + GSK 2336805 (polymerase + NS5A)
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VX 135 + daclatasvir (BMS NS5A)
PRICING FACTORS
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Better, New and Improved
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Better Efficacy
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Better Side Effect/Resistance Profile
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Better Administration: QD, FDC
PRICING FACTORS
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Last approved drug in same class
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Expected market share timeframe
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Input from payers
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Corporate culture and finances
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What the market will bear???
PRICING FACTORS
Persuasive Pricing Factors:
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Drug Development Costs?
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Marketing Costs?
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Manufacturing Costs?
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Access Program Costs?
PRICE INCREASES
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Medical Inflation Rate from 2-12 to 2-13
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Medical Services = 3.9%
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Physician Services = 2.5%
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Hospital Services = 5.4%
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Other company increases
ANNUAL AVERAGE HIV
PRICE INCREASES
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Abbott: Norvir 38% - Kaletra 3.6%
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BI: Aptivus 4.3% - Viramune 15.2%
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BMS: Sustiva 7.7% - Atripla 9.7%
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Gilead: Viread 13.5% - Emtriva 10.2%
Truvada 10.3% - Complera 9.1%
ANNUAL AVERAGE HIV
PRICE INCREASES
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Jenssen: Prezista 8.3%
Intelence 6.5%, Edurant 8.8%
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Merck: Isentress 5.9%
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ViiV: Combivir 8.1% - Lexiva 9.0%
HCV DRUG
PRICE INCREASES
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Incivek – Vertex = 12.3% since 2011
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Victrelis – Merck = 25% since 2011
COMPANY ASSESSMENTS
Original Pricing
Price Increases
AbbVie/Abbott
Abbott
BI
BI
BMS
BMS
Gilead
Gilead
GSK/ViiV
ViiV
Merck (HCV only) Merck (HCV only)
Vertex
Vertex
Merck/Janssen*
Merck*
Access*
AbbVie
Janssen
BMS
Gilead
ViiV
Merck
Vertex
*Good Assessment
HCV DRUG
TREATMENT COSTS
Wholesale Acquisition Cost (WAC):
The price paid by a wholesaler’s supplier,
typically the manufacturer of the drug. WAC
is the price manufacturers release publicly
and is sometimes called the “list price”.
Publicly disclosed or listed WAC amounts
may not reflect all discounts.
HCV DRUG
TREATMENT COSTS
Pegylated Interferon + Ribavirin Current WAC Price
With Generic Ribavirin
With Brand (Rebetrol or Copegus)
Total
after
12 wks
Total
after
24 wks
Total
after
36 wks
Total
after
48 wks
PegIntron
$7,858
$15,717
$23,575
$31,434
Pegasus
$8,338
$16,676
$25,014
$33,352
Total
after
12 wks
Total
after
24 wks
Total
after
36 wks
Total
after
48 wks
PegIntron
$11,312
$22,625
$33,937
$45,250
Pegasus
$14,969
$29,939
$44,908
$59,878
HCV DRUG
TREATMENT COSTS
Incivek Current WAC Price
2nd Price Increases Since Approval in 2011 = 12.3%
12 Weeks
24 Weeks
36 Weeks
48 Weeks
Total
Incivek
Incivek
Pegasus
Ribavirin
(generic)
Total
after
12 wks
Pegasus+
Ribavirin
(generic)
Total
after
24 wks
Pegasus+
Ribavirin
(generic)
Total
after
32 wks
Pegasus+
Ribavirin
(generic)
Total
after
48 wks
$55,228
$8,083
$255
$63,566
$8,338
$71,904
$8,338
$80,242
$8,338
$88,580
$55,228
HCV DRUG
TREATMENT COSTS
Victrelis Current WAC Price
2nd Price Increases Since Approval in 2011 = 14.5%
4 Weeks
24 Weeks
36 Weeks
PegIntron +
Ribavarin
(generic)
Victrelis
PegIntron +
Ribavarin
(generic)
Total
after
24 wks
$2,619
$25,185
$13,097
$40,902
48 Weeks
Victrelis
PegIntron +
Ribavarin
(generic)
Total
after
36 wks
$15,111
$7,858
$63,871
Victrelis
PegIntron +
Ribavarin
(generic)
Total
after
48 wks
Total
Victrelis
$15,111
$7,858
$86,841
$55,407
HCV DRUG
TREATMENT COSTS
BETTER EFFICACY/SIDE EFFECT/ADMINISTRATION
= HIGHER PRICES THAN INF/RBV
+ INCIVEK OR + VICTRELIS ($85,000)
PROJECTIONS:
JANSSEN PI + INF/RBV (12, 24, 48)
= $85,000 PLUS?
GS 7977 (NS5B) FOR 12 WEEKS
GS 5885 (NS5A) FOR 12 WEEKS
= $55,000 PLUS
= $55,000 PLUS
= $110,000 PLUS
HCV DRUG
TREATMENT COSTS
BETTER EFFICACY/SIDE EFFECT/ADMINISTRATION
= HIGHER PRICES THAN INF/RBV
+ INCIVEK OR + VICTRELIS ($85,000)
PROJECTIONS:
NEW PI FOR 12 WEEKS (AB450/R) = $55,000
PLUS $720 NORVIR + $255 RBV
= $55,975
NEW NS5A FOR 12 WEEKS (AB267) = $55,000 PLUS
NEW NON-NUC 12 WEEKS (AB333) = $55,000 PLUS
= $165,975 PLUS
FAIR PRICING COALITION
fairpricingcoalition.org
Bill Arnold
Paul Arons
Jeff Berry
Lanny Cross
Lynda Dee
David Evans
Murray Penner
Bill Arnold
Bruce Burkett
Ryan Clary
Lanny Cross
Lynda Dee
David Evans
Michael Ninburg
Murray Penner
Lorren Sandt